8/12/2010 1

DRUG CONTROL AND REGISTRATION

SIRIPORN CHAWANONPharmacist, professional level

Drug Control DivisionThai Food and Drug Administration

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OUTLINE

• Drug Control System

• The Organization of Drug Control Division

• Drug Licensing and Registration

•Drug Registration system

•Safety Monitoring Program

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DRUG CONTROL SYSTEM

MINISTRY OF PUBLIC HEALTHFOOD AND DRUG ADMINISTRATION (FDA)DEPARTMENT OF MEDICAL SCIENCESPROVINCIAL HEALTH OFFICES

THAI FDAPRE-MARKETING: LICENSING

DRUG REGISTRATION

POST-MARKETING: INSPECTIONSURVEILLANCE ADR MONITORING

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The Organization Chart of Drug Control Division

Drug Control Division

Policy and SystemDevelopment Section

Generic Drug Section

New Drug Section

Biological ProductSection

Herbal and Traditional Drug Section

International Affairs and IND section

Advertising Control Section

National List of Essential Medicines

Development Section

Veterinary Drug Section

Generic Product industry and Intellectual Property Section

Administrative Sub-division

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Thai Regulatory System

The legislative basis of this system is the Drug Act BE 2510 (1967) and amendments

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Thai Regulatory System

The Drug Act provides that decisions of the Secretary-General, FDA, be made with advice of a Drug Board made up of principal relevant Departmental Directors General in the MoPH as well as representatives from related organizations, plus five to nine drug experts.

The Drug Board meets monthly and may give recommendations or opinions on licensing and registration decisions such as approved, withdraw or suspend the licenses.

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Licensing

The drug Act requires that persons who wish to sell, produce, or import drugs into Thailand have to obtain a license from the FDA.

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RegistrationRegistration• Qualified person: Authorized licensees• To ensure efficacy safety and quality

of drugs• Upon receipt of Drug Registration

Certificate, the drug can be lawfully marketed.

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DRUG REGISTRATION AND APPROVAL

New Drugs and New Generic Drugs New Drug Section(for human uses)

Generic Drugs (for human uses) Generic Drug Section

Biological Products Biological Product Section(for human or veterinary uses)

Veterinary Drugs Veterinary and Pharmaceutical chemicals Section(not include Biological Products and Traditional and Herbal Drugs)

Traditional and Herbal Drugs Traditional and Herbal Medicine Section(for human or veterinary uses)

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DRUG REGISTRATION PROCESS

Applicants: Only authorized licensees are qualified to apply forproduct registration.

Manufacturing plants :GMP compliance

2 steps:Step 1: Application for permission to manufacture or import of

drug samples – One Stop Service CenterStep 2: Application for product registration approval

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Flow Chart of Drug Review Process

ApplicantApplicant

ApplicationApplication

Pre-filing screening ReviewPre-filing screening Review

Review by Experts/Subcommittee/CommitteeReview by Experts/Subcommittee/Committee

Make Decision by FDAMake Decision by FDA

ApprovedApproved RevisedRevised RejectedRejected

[Completeness Review]

[Technical Review]

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Thai FDA Classified modern medicine into 3 categories :

New drugs

New generic drugs: Pharmaceutical products with the same active ingredients, doses and dosage forms as those of new compounds (new drugs) registered after 1992 but manufactured by different manufacturers

Generic drugs.

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Thai FDA Classified modern medicine into 3 categories :

New drugs: registrations is the most stringent of allrequire a complete set of product dossiers

Generic drugs. The registrations require basically dossiers on product manufacturing and quality control together with product information.

New generic drugs: In addition to the required dossiers for generic submission, the new generic registrations require dossiers of bioequivalence studies as well as literature documents for supporting safety and efficacy

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ASEAN HARMONIZATION PRODUCT i.e.

ACTR , ACTD4 Technical Guidelines(1) Analytical Validation guideline(2) BA/BE Studies guideline(3) Process Validation guideline(4) Stability Study.

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Process of New Drug Registration

Track 1 : Standard Review

210 - 280 working days

Track 2 : Accelerated or Priority Review

(Drugs for public health problems / life

threatening)

100-130 working days

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Process of New Generic Drug Registration

Track 1 : Standard Review

110 working days

Track 2 : Accelerated or Priority Review

(Drugs for public health problems / life

threatening)

70 working days

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New Drug Registration (ASEAN Harmonization)

ASEAN Common Technical Dossiers (ACTD)Documents to be submitted 4 Parts

Part 1: Administrative Data and Product InformationPart 2: Quality DocumentPart 3: Nonclinical DocumentPart 4: Clinical Document

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New Drug Registration System

New DrugStep I Experts/Subcommittee

Approval

Conditional approval

SMP & Limited distribution (2 yrs)

Unconditional approval

Step II

Voluntary Spontaneous ADR Reporting System

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Conditional Approval

Safety Monitoring Program (SMP) will be conducted for approx. 2 years.Drug packages must bear labeling to show conditional approval status.

Triangle shows monitoring status.Specially-control drug

Limited distribution only throughmedical institutes or hospitals

should monitoring

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Objectives:• To confirm the drug safety in Thai

patients • To generate earlier safety signals and

gather more safety information of new drugs before granting and unconditional approval.

• To more rigorously control the usage of new drugs

Why SMP?

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Objectives: • To encourage physicians, pharmacist

and other health professionals to have more concerns on the safety of new drugs and their usage.

Why SMP? (2)

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• Capacity building on drug evaluation andregistration in order to be prepared for ASEANPharmaceutical Harmonization and WHO assessment of regulartory system.

• Collaboration and communication links with other NRAs in order to strengthen professional competence and exchange information (MOU with TGA, US FDA Regulator Training Program for vaccine)

• BE study submitted for registration should beconducted in compliance with the ICH GCP as wellas GLP standard.

What Have Been Currently Done ?

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• Encourage current and new domestic manufacturer to upgrade their quality standard.

• The proposed revision of Drug Act is expected to bring about better drug regulatory implications

• One Stop Service Center has been established for submitted applications which can be processed and approved within a short time period.

What Have Been Currently Done ?

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• Maintain a balance between ensuring a product is safe, efficacious and of good quality and not delaying public access to the products.by Clearly separate the tracks of registration submission into standard review and priority review and Reduce the timelines for each steps were announced.

What Have Been Currently Done ?

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1. The fast track pathway for the emergent medicine, such as, neoplastic, H.I.V., antituberculous drug, antiviral vaccine, can reduce the consideration period from 280 working days to 130 working days.

2. Thailand's MoPH issued a compulsory license for HIV drug (EFFAVIRENZE, lopinavir/ritronavir) and drug for other diseases with public health consequences such as cancer or other chronic diseases (letrozole Imatinib errotinib docetaxelclopidogrel)

The proposed policies to promote the accessibility of the medicine, which can solve the public health’s problem

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3. The personnel’s efficiency should be more developed and improve competence

4. the ASEAN Economic Ministers signed the ASEAN Sectoral Mutual Recognition Arrangement (MRA) for Good Manufacturing Practice (GMP).

The proposed policies to promote theaccessibility of the medicine, which can solve the public health’s problem

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THANK YOU FOR YOUR ATTENTION

THANK YOU FOR YOUR ATTENTION

www.fda.moph.go.thE-mail: be.study@gmail.com

www.fda.moph.go.thE-mail: be.study@gmail.com